Clinical Trials in Canada / NCT00070499
Active, not recruiting Phase 2

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

NCT00070499 · tracked via the Priya Life Science Canada tracker
Phase
Phase 2
Started
2004-08-15
Last updated
2026-08-26

Condition(s) studied

Chronic Myeloid Leukemia, BCR-ABL1 Positive

Investigational drug(s) / intervention(s)

Dasatinib →Imatinib Mesylate →Laboratory Biomarker Analysis

Dasatinib: Given PO

Imatinib Mesylate: Given PO

Laboratory Biomarker Analysis: Correlative studies

Study summary

This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients must have CML in chronic phase based on bone marrow aspiration and biopsy and peripheral blood counts obtained within 28 days before registration * Patients must be registered on this study within 180 days after the date of first being diagnosed with CML, based on a cytogenetic or molecular analysis of peripheral blood or bone marrow, demonstrating the presence of the Philadelphia chromosome or variants of the (9;22) translocation or testing positive for Bcr-Abl by real time-polymerase chain reaction (RT-PCR); patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible * Patients must have Zubrod performance status 0-2 * Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide * Patients must not have received any prior chemotherapy regimen for peripheral blood stem cell mobilization; (prior collection of unmobilized peripheral blood stem cells is permitted) * Serum bilirubin =\< 2.0 x the institutional upper limit of the normal (IULN) * Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) =\< 2.0 x the IULN * Patients (Southwestern Oncology Group \[SWOG\] institutions only) must be registered on SWOG-9007, "Cytogenetic Studies in Leukemia Patients;" collection of the pretreatment bone marrow specimen must be completed within 28 days prior to registration; the pretreatment bone marrow specimen must be submitted to an approved Southwest Oncology Group Cytogenetics Laboratory for cytogenetic analysis as described, and an aliquot of the bone marrow (or peripheral blood if the marrow aspiration is a dry tap) must be submitted for fluorescent in situ hybridization (FISH) analysis; note that protocol SWOG-9007 also requires submission of bone marrow specimens at the time of progression to the accelerated or blastic phase of CML or the loss of complete hematologic response and every six months while the patient is on this study * Patients (SWOG institutions only) must be registered on S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary;" specimens of peripheral blood and bone marrow must be submitted to the Southwest Oncology Group Lymphoid Leukemia and CML Centralized Laboratory in Seattle, Washington; collection of pretreatment blood and marrow specimens must be completed within 28 days prior to registration; note that this study also requires submission of peripheral blood and bone marrow specimens at various times after entry into the study * Patients must not have undergone major surgery within 28 days before registration, and must have fully recovered from any other prior major surgery * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years * Patients must have an electrocardiogram (ECG) within 42 days prior to registration, and must not have any of the following cardiac symptoms prior to entry on study: * Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within 6 months of study entry * Diagnosed or suspected congenital long QT syndrome * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) * Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 450 msec) * Uncontrolled hypertension * Patients must not have a history of significant bleeding disorder unrelated to cancer, including: * Congenital bleeding disorders (e.g., von Willebrand's disease) * Acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies) * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Primary outcome measure(s)

Trial sites (340)

FacilityCityRegionStatus
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
City of Hope Comprehensive Cancer Center Duarte California
Kaiser Permanente-Fremont Fremont California
USC / Norris Comprehensive Cancer Center Los Angeles California
Kaiser Permanente-Oakland Oakland California
Kaiser Permanente-Redwood City Redwood City California
Kaiser Permanente-Richmond Richmond California
Kaiser Permanente-Roseville Roseville California
Kaiser Permanente-South Sacramento Sacramento California
Kaiser Permanente Sacramento Medical Center Sacramento California
Kaiser Permanente-San Francisco San Francisco California
Kaiser Permanente-Santa Teresa-San Jose San Jose California
Kaiser Permanente San Leandro San Leandro California
Kaiser Permanente-San Rafael San Rafael California
Kaiser Permanente Medical Center - Santa Clara Santa Clara California
Kaiser Permanente-Santa Rosa Santa Rosa California
Kaiser Permanente-South San Francisco South San Francisco California
Kaiser Permanente-Stockton Stockton California
Kaiser Permanente-Vallejo Vallejo California
Kaiser Permanente-Walnut Creek Walnut Creek California
Rocky Mountain Regional VA Medical Center Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
Poudre Valley Hospital Fort Collins Colorado
Montrose Memorial Hospital Montrose Colorado
Intermountain Health Lutheran Hospital Wheat Ridge Colorado
Beebe Medical Center Lewes Delaware
Christiana Care Health System-Christiana Hospital Newark Delaware
Saint Francis Hospital - Wilmington Wilmington Delaware
Baptist MD Anderson Cancer Center Jacksonville Florida
Mayo Clinic in Florida Jacksonville Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Orlando Health Cancer Institute Orlando Florida
Moffitt Cancer Center Tampa Florida
OSF Saint Anthony's Health Center Alton Illinois
Rush-Copley Medical Center Aurora Illinois
OSF Saint Joseph Medical Center Bloomington Illinois
Graham Hospital Association Canton Illinois
Memorial Hospital Carthage Illinois
Hematology and Oncology Associates Chicago Illinois
Northwestern University Chicago Illinois

+ 300 more sites — see the full list on the official registry below.

On this site

📄 Sprycel (dasatinib) drug profile →

More National Cancer Institute (NCI) trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00070499 on ClinicalTrials.gov ↗ ← All trials in Canada